Shape memory alloy actuators

ABSTRACT

An electrically insulative layer of a shape memory alloy (SMA) actuator includes an inorganic material formed upon a portion of an SMA substrate. A conductive material formed upon a portion of the electrically insulative layer in a trace pattern includes a first end, a second end, and a heating element disposed between the first and second ends. The SMA substrate is trained to deform at a transition temperature achieved when electricity is conducted through the conductive material via first and second interconnect pads terminating the first and second ends of the trace pattern.

CROSS-REFERENCE TO RELATED APPLICATION

[0001] Cross-reference is hereby made to commonly assigned related U.S.application Ser. No. ______ to David Anderson, et al., filedconcurrently herewith, entitled “Shape Memory Alloy Actuators” (AttorneyDocket No. P-9578.00).

FIELD OF THE INVENTION

[0002] Embodiments of the present invention relate generally to shapememory alloy (SMA) actuators and more particularly to means for formingSMA actuators and incorporating such actuators into elongated medicaldevices.

BACKGROUND

[0003] The term SMA is applied to a group of metallic materials which,when subjected to appropriate thermal loading, are able to return to apreviously defined shape or size. Generally an SMA material may beplastically deformed at some relatively low temperature and will returnto a pre-deformation shape upon exposure to some higher temperature bymeans of a micro-structural transformation from a flexible martensiticphase at the low temperature to an austenitic phase at a highertemperature. The temperature at which the transformation takes place isknown as the activation temperature. In one example, a TiNi alloy has anactivation temperature of approximately 70° C. An SMA is “trained” intoa particular shape by heating it well beyond its activation temperatureto its annealing temperature where it is held for a period of time. Inone example, a TiNi alloy is constrained in a desired shape and thenheated to 510° C. and held at that temperature for approximately fifteenminutes.

[0004] In the field of medical devices SMA materials, for example TiNialloys, such as Nitinol, or Cu alloys, may form a basis for actuatorsdesigned to impart controlled deformation to elongated interventionaldevices. Examples of these devices include delivery catheters, guidewires, electrophysiology catheters, ablation catheters, and electricalleads, all of which require a degree of steering to access target siteswithin a body; that steering is facilitated by an SMA actuator. An SMAactuator within an interventional device typically includes a strip ofSMA material extending along a portion of a length of the device and oneor more resistive heating elements through which electrical current isdirected. Each heating element is attached to a surface of the SMAstrip, in proximity to portions of the SMA strip that have been trainedto bend upon application of thermal loading. A layer of electricallyinsulating material is disposed over a portion of the SMA strip on whicha conductive material is deposited or applied in a trace pattern formingthe heating element. Electrical current is directed through theconductive trace from wires attached to interconnect pads that terminateeach end of the trace. In this way, the SMA material is heat activatedwhile insulated from the electrical current. It is important that,during many cycles of activation, the insulative layer does not crack ordelaminate from the surface of the SMA strip.

BRIEF DESCRIPTION OF THE DRAWINGS

[0005]FIG. 1A is a plan view including a partial section of an elongatedmedical device including an SMA actuator.

[0006]FIG. 1B is a plan view of the exemplary device of FIG. 1A whereina current has been passed through heating elements of the SMA actuator.

[0007]FIG. 1C is a plan view including a partial section of anotherembodiment of an elongated medical device including an SMA actuator.

[0008]FIG. 1D is a plan view of the exemplary device of FIG. 1C whereina current has been passed through heating elements of the SMA actuator.

[0009]FIG. 2A is a perspective view of an SMA substrate or strip thatwould be incorporated in an SMA actuator.

[0010]FIG. 2B is a plan view of a portion of a surface of an SMAactuator.

[0011]FIG. 3 is a section view through a portion of an SMA actuatoraccording an embodiment of the present invention.

[0012]FIG. 4 is a section view through a portion of an SMA actuatoraccording to an alternate embodiment of the present invention.

[0013] FIGS. 5A-D are section views illustrating steps, according toembodiments of the present invention, for forming the SMA actuatorillustrated in FIG. 4.

DETAILED DESCRIPTION

[0014] FIGS. 1A-D illustrate two examples of elongated medical deviceseach incorporating an SMA actuator, wherein each actuator serves tocontrol deformation of a portion of each device. FIG. 1A is a plan viewwith partial section of an elongated medical device 300 including an SMAactuator 56. As illustrated in FIG. 1A, medical device 300 furtherincludes a shaft 305, a hub 303 terminating a proximal end of shaft 305,and conductor wires 57 coupled to SMA actuator 56. SMA actuator 56,positioned within a distal portion 100 of shaft 305, includes aplurality of heating elements (not shown), electrically insulated froman SMA substrate, through which current flows fed by wires 57; wires 57,extending proximally and joined to electrical contacts (not shown) onhub 303, carry current to heat portions of the SMA substrate to anactivation temperature. At the activation temperature, portions of theSMA substrate revert to a trained shape, for example a shape 200 asillustrated in FIG. 1B. FIG. 1B is a plan view of the exemplary device300 of FIG. 1A wherein a current has been passed through heatingelements of SMA actuator 56, locations of which heating elementscorrespond to bends 11, 12, and 13. When the current is cut, either anexternal force or a spring element (not shown) joined to shaft 605 inproximity of SMA actuator 56 returns distal portion 100 back to asubstantially straight form as illustrated in FIG. 1A. Device 300,positioned within a lumen of another elongated medical device, may beused to steer or guide a distal portion of the other device viacontrolled deformation of actuator 56 at locations corresponding tobends 11, 12, and 13, either all together, as illustrated in FIG. 1B, orindividually, or in paired combinations.

[0015]FIG. 1C is a plan view including a partial section of anotherembodiment of an elongated medical device 600 including an SMA actuator10 embedded in a portion of a wall 625 of a shaft 605. As illustrated inFIG. 1C, medical device 600 further includes a hub 603 terminating aproximal end of shaft 605, a lumen 615 extending along shaft 605, from adistal portion 610 through hub 603, and conductor wires 17 coupled toSMA actuator 10. SMA actuator 10, positioned within distal portion 610of shaft 605, includes a plurality of heating elements (not shown),electrically insulated from an SMA substrate, through which currentflows fed by wires 17; wires 17, extending proximally and joined toelectrical contacts (not shown) on hub 603, carry current to heatportions of the SMA substrate to an activation temperature. At theactivation temperature, portions of the SMA substrate revert to atrained shape, for example a bend 620 as illustrated in FIG. 1D. FIG. 1Dis a plan view of the exemplary device 600 of FIG. 1C wherein a currenthas been passed through a heating element of SMA actuator 10, a locationof which heating element corresponds to bend 620. When the current iscut, either an external force or a spring element (not shown), forexample embedded in a portion of shaft wall 625, returns distal portion610 back to a substantially straight form as illustrated in FIG. 1C.Lumen 615 of device 600, may form a pathway to slideably engage anotherelongated medical device, guiding the other device via controlleddeformation of distal portion 610 by actuator 10 resulting in bend 620.

[0016] FIGS. 2A-B illustrate portions of exemplary SMA actuators thatmay be incorporated into an elongated medical device, for example device300 illustrated in FIGS. 1A-B. FIG. 2A is a perspective view of an SMAsubstrate or strip 20 that would be incorporated into an SMA actuator,such as SMA actuator 56 illustrated in FIG. 1A. Embodiments of thepresent invention include an SMA substrate, such as strip 20, having athickness between approximately 0.001 inch and approximately 0.1 inch; awidth and a length of strip 20 depends upon construction and functionalrequirements of a medical device into which strip 20 is integrated. Asillustrated in FIG. 2A strip 20 includes a surface 500, which accordingto embodiments of the present invention includes a layer of an inorganicelectrically insulative material formed or deposited directly thereon,examples of which include oxides such as silicon oxide, titanium oxide,or aluminum oxide, nitrides such as boron nitride, silicon nitride,titanium nitride, or aluminum nitride, and carbides such as siliconcarbide, titanium carbide, or aluminum carbide. Means for forming theinorganic material layer are well known to those skilled in the art andinclude vacuum deposition methods, such as sputtering, evaporativemetalization, plasma assisted vapor deposition, or chemical vapordeposition; other methods include precipitation coating and printingfollowed by sintering. In an alternate embodiment an SMA substrate, suchas strip 20, is a TiNi alloy and a native oxide of the TiNi alloy formsthe layer of inorganic electrically insulative material; the nativeoxide may be chemically, electrochemically or thermally formed onsurface 500. In yet another embodiment, a deposited non-native oxide,nitride, or carbide, such as one selected from those mentioned above, incombination with a native oxide forms the layer of electricallyinsulative material on surface 500.

[0017] According to embodiments of the present invention, an SMAsubstrate, such as strip 20, is trained to bend, for example in thedirection indicated by arrow A in FIG. 2A, after deposition or formationof an inorganic electrically insulative layer upon surface 500, sincethe inorganic insulative layer will not break down under trainingtemperatures. Training temperatures for TiNi alloys range betweenapproximately 300° C. and approximately 800° C. Alternately an SMAsubstrate, such as strip 20, may be trained to bend before deposition orformation of the inorganic insulative layer if a temperature of thesubstrate, during a deposition or formation process, is maintained belowan activation temperature of the substrate. Furthermore, according to analternate embodiment, an additional layer of an organic material isdeposited over the inorganic layer to form a composite electricallyinsulative layer. Examples of suitable organic materials includepolyimide, parylene, benzocyclobutene (BCB), and fluoropolymers such aspolytetrafluoroethylene (PTFE). Means for forming the additional layerare well known to those skilled in the art and include dip coating, spaycoating, spin coating, chemical vapor deposition, plasma assisted vapordeposition and screen printing; the additional layer being formedfollowing training of the SMA substrate and at a temperature below anactivation temperature of the substrate. An activation temperature foran SMA actuator included in an interventional medical device must besufficiently high to avoid accidental activation at body temperature; atemperature threshold consistent with this requirement and having asafety factor built in is approximately 60° C. This lower threshold ofapproximately 60° C. may also prevent accidental activation duringshipping of the medical device. An activation temperature must also besufficiently low to avoid thermal damage to body tissues and fluids; amaximum temperature consistent with this requirement is approximately100° C., but will depend upon thermal insulation and, or cooling meansemployed in a medical device incorporating an SMA actuator.

[0018]FIG. 2B is a plan view of a portion of a surface of an SMAactuator 50. FIG. 2B illustrates a group of conductive trace patterns;portions of the conductive trace patterns are formed either on a firstlayer, a second layer, or between the first and second layer of amulti-layer electrical insulation 1 formed on a surface of an SMAsubstrate, such as strip 20 illustrated in FIG. 2A. As illustrated inFIG. 2B, conductive trace pattern includes heating element traces 2,which are formed on first layer of insulation 1, signal traces 4, 5,which are formed on second layer of insulation 1, and conductive vias 3,9, which traverse second layer in order to electrically couple heatingelement signal traces 2 on first layer with signal traces 4, 5 on secondlayer. Each signal trace 4 extends from an interconnect pad 6 throughvia 3 to heating element trace 2, while signal trace 5 extends from allheating element traces 2 through vias 9 to a common interconnect pad 7.According to embodiments of the present invention, multi-layerinsulation 1 is formed of an inorganic electrically insulative material,examples of which are presented above, deposited or formed directly onthe SMA substrate. Portions of conductive trace pattern deposited uponeach layer of multi-layer insulation 1, according to one embodiment, areformed of a first layer of titanium, a second layer of gold and a thirdlayer of titanium and each interconnect pad 6, 7 is formed of golddeposited upon the second layer of insulation 1. Details regardingpattern designs, application processes, thicknesses, and materials ofconductive traces that may be included in embodiments of the presentinvention are known to those skilled in the arts of VLSI andphotolithography.

[0019] Section views in FIGS. 3 and 4 illustrate embodiments of thepresent invention in two basic forms. FIG. 3 is a section view through aportion of an SMA actuator 30 including one segment of a conductivetrace 32 that may be a portion of a heating element trace, such as aheating element trace 2 illustrated in FIG. 2B. As illustrated in FIG.3, SMA actuator 30 further includes an SMA substrate 350, a firstinsulative layer 31, electrically isolating conductive trace 32 from SMAsubstrate 350, and a second insulative layer 33 covering and surroundingconductive trace 32 to electrically isolate conductive trace 32 fromadditional conductive traces that may be included in a pattern, such asthe pattern illustrated in FIG. 2B. According to embodiments of thepresent invention, first insulative layer 31, including an inorganicmaterial, is deposited or formed directly on substrate 350, as describedin conjunction with FIG. 2A. Conductive materials are deposited orapplied on insulative layer 31, creating conductive trace 32, forexample by etching, and then second insulative layer 33, including aninorganic material, is deposited or applied over conductive trace 32. Inan alternate embodiment, second insulative layer 33 includes an organicelectrically insulative material; examples of suitable organic materialsinclude polyimide, parylene, benzocyclobutene (BCB), and fluoropolymerssuch as polytetrafluoroethylene (PTFE). Means for forming insulativelayer 33 include dip coating, spray coating, spin coating, chemicalvapor deposition, plasma assisted vapor deposition and screen-printing.Training of SMA substrate 350 may follow or precede formation of firstinsulative layer 31, as previously described in conjunction with FIG.2A.

[0020]FIG. 4 is a section view through a portion of an SMA actuator 40including one segment of a conductive trace 42. According to alternateembodiments of the present invention, a groove in a surface of an SMAsubstrate 450 (reference FIG. 5A) establishes a pattern for conductivetrace 42, the pattern including a heating element trace disposed betweensignal traces, similar to one of heating element traces 2 andcorresponding signal traces 4,5 illustrated in FIG. 2B. As illustratedin FIG. 4, an insulative layer 41 is disposed between conductive trace42 and SMA substrate 450 electrically isolating conductive trace 42 froman SMA substrate 450. According to embodiments of the present invention,insulative layer 41 includes an inorganic material, examples of whichare given in conjunction with FIG. 2A, formed directly on SMA substrate450. Training of SMA substrate 450 may follow or precede formation offirst insulative layer 41 including an inorganic material, as previouslydescribed in conjunction with FIG. 2A. According to alternateembodiments of the present invention, insulative layer 41 includes anorganic material, formed directly on SMA substrate 450 followingtraining of substrate 450. Selected organic materials for insulativelayer 41 include those which may be deposited or applied at atemperature below an activation temperature of SMA substrate 450 andthose which will not degrade at the activation temperature of SMAsubstrate 450; examples of such materials include polyimide, parylene,benzocyclobutene (BCB), and fluoropolymers such aspolytetrafluoroethylene (PTFE). Means for forming insulative layer 41include dip coating, spray coating, spin coating, chemical vapordeposition, plasma assisted vapor deposition and screen-printing.

[0021] FIGS. 5A-D are section views illustrating steps, according toembodiments of the present invention, for forming SMA actuator 40illustrated in FIG. 4. FIG. 5A illustrates SMA substrate 450 including agroove 510 formed in a surface 515; groove 510 is formed, for example bya machining process. FIG. 5B illustrates a layer of electricallyinsulative material 511 formed on surface 515 and within groove 510.FIG. 5C illustrates a layer of conductive material 512 formed over layerof insulative material 511. FIG. 5D illustrates insulative layer 41 andconductive trace 42 left in groove 510 after polishing excess insulativematerial 511 and conductive material 512 from surface 515. Asillustrated in FIG. 5D, conductive trace 42 is flush with surface 515following polishing; in one example, according to this embodiment,groove 510 is formed having a width of approximately 25 micrometer and adepth of approximately 1.2 micrometer approximately matching apredetermined combined thickness of insulative layer 41 and conductivetrace 42. According to alternate embodiments of the present invention,groove 510 is formed deeper than a resultant combined thickness of theinsulative layer 41 and conductive trace 42 so that conductive trace isrecessed from surface 515.

EXAMPLES

[0022] Minimum theoretical thicknesses having sufficient dielectricstrength for operating voltages of 100V, 10V, and 1V applied acrossconductive traces on SMA actuators were calculated for insulating layersof Silicon Nitride, Aluminum Nitride, Boron Nitride, and polyimideaccording to the following formula:

Thickness=voltage/dielectric strength.

[0023] A dielectric strength for Silicon Nitride was estimated to be17700 volts/millimeter; a dielectric strength for Aluminum Nitride wasestimated to be 15,000 volts/millimeter; a dielectric strength for BoronNitride was estimated to be 3,750 volts/millimeter; a dielectricstrength for polyimide was estimated to be 157,500 volts/millimeter.Results are presented in Table 1. TABLE 1 Thickness, 100 V Thickness, 10V Thickness, 1 V (micrometer) (micrometer) (micrometer) Silicon Nitride5.65 0.56 0.06 Aluminum Nitride 6.67 0.67 0.07 Boron Nitride 26.7 2.670.27 Polyimide 0.64 0.064 0.0064

[0024] Finally, it will be appreciated by those skilled in the art thatnumerous alternative forms of SMA substrates and trace patterns includedin SMA actuators and employed in medical devices are within the spiritof the present invention. For example, SMA actuators according to thepresent invention can include conductive trace patterns on two or moresurfaces of an SMA substrate or an additional layer or layers of non-SMAmaterial joined to an SMA substrate, which serve to enhancebiocompatibility or radiopacity in a medical device application. Hence,descriptions of particular embodiments provided herein are intended asexemplary, not limiting, with regard to the following claims.

1. An elongated medical device adapted for controlled deformation bymeans of one or more actuators, the one or more actuators comprising: ashape memory alloy (SMA) substrate including a surface and a grooveformed upon the surface establishing a trace pattern; an electricallyinsulative layer formed upon a portion of the surface of the SMAsubstrate, which includes the groove; the insulative layer including aninorganic material; a conductive material formed upon the electricallyinsulative layer according to the trace pattern and including a firstend, a second end, and a heating element disposed between the first endand the second end; a first interconnect pad terminating the first endof the trace pattern; and a second interconnect pad terminating thesecond end of the trace pattern; wherein the SMA substrate is trained todeform at a transition temperature achieved when electricity isconducted through the conductive material via the first and secondinterconnect pads.
 2. The medical device of claim 1, wherein theelectrically insulative layer further includes an organic material.3-13. (Cancelled)
 14. The medical device of claim 1, wherein theinorganic material comprises an oxide.
 15. The medical device of claim14, wherein the SMA substrate comprises Nitinol and the inorganicmaterial comprises a native oxide of Nitinol.
 16. The medical device ofclaim 1, wherein the inorganic material comprises a nitride.
 17. Themedical device of claim 16, wherein the nitride is selected from thegroup consisting of boron nitride, silicon nitride, and aluminumnitride.
 18. The medical device of claim 1, wherein the inorganicmaterial comprises carbide.
 19. The medical device of claim 1, wherein athickness of the portion of the electrically insulative layer over whichthe trace pattern of conductive material is formed is betweenapproximately 0.5 micrometer and approximately 1 micrometer.
 20. Themedical device of claim 1, wherein a thickness of the portion of theelectrically insulative layer over which the trace pattern of conductivematerial is formed is less than approximately 0.5 micrometer.
 21. Themedical device of claim 1, wherein a dielectric strength of the portionof the electrically insulative layer over which the trace pattern ofconductive material is formed is sufficient for an applied operatingvoltage greater than approximately 100V.
 22. The medical device of claim1, wherein a dielectric strength of the portion of the electricallyinsulative layer over which the trace pattern of conductive material isformed is sufficient for an applied operating voltage greater thanapproximately 10V.
 23. The medical device of claim 1, wherein adielectric strength of the portion of the electrically insulative layerover which the trace pattern of conductive material is formed issufficient for an applied operating voltage between approximately 1V andapproximately 10V. 24-26. (Cancelled)
 27. A method for manufacturing ashape memory alloy (SMA) actuator, comprising: forming an electricallyinsulative layer including an inorganic material on a surface of an SMAsubstrate; forming a conductive material on a portion of the insulatinglayer in a trace pattern; and forming a groove on the surface of the SMAsubstrate to establish a portion of the trace pattern in the SMAsubstrate prior to formation of the insulative layer.
 28. A method formanufacturing a shape memory alloy (SMA) actuator, comprising: formingan electrically insulative layer including an inorganic material on asurface of an SMA substrate; and forming a conductive material on aportion of the insulating layer in a trace pattern; wherein means forforming the insulative layer includes a vacuum deposition method. 29.The method of claim 27, wherein means for forming the insulative layeris selected from the group consisting of printing and coating.
 30. Themethod of claim 27, wherein the inorganic material comprises an oxide.31. The method of claim 30, wherein the oxide is a native oxide andmeans for forming the insulative layer is selected from the groupconsisting of electrochemically forming the native oxide, chemicallyforming the native oxide and thermally forming the native oxide.
 32. Themethod of claim 27, wherein the inorganic material comprises a nitride.33. The method of claim 32, wherein the nitride is selected from thegroup consisting of boron nitride, silicon nitride, and aluminumnitride.
 34. The method of claim 27, wherein the inorganic materialcomprises carbide.
 35. A shape memory alloy (SMA) actuator comprising:an SMA substrate including a surface and a groove formed upon thesurface establishing a trace pattern; an electrically insulative layerformed upon a portion of the surface of the SMA substrate, whichincludes the groove; the insulative layer including an inorganicmaterial; a conductive material formed upon the electrically insulativelayer according to the trace pattern and including a first end, a secondend, and a heating element disposed between the first end and the secondend; a first interconnect pad terminating the first end of the tracepattern; and a second interconnect pad terminating the second end of thetrace pattern; wherein the SMA substrate is trained to deform at atransition temperature achieved when electricity is conducted throughthe conductive material via the first and second interconnect pads. 36.The SMA actuator of claim 35, wherein the electrically insulative layerfurther includes an organic material. 37-47. (Cancelled)
 48. The SMAactuator of claim 35, wherein the electrically insulative layercomprises an oxide.
 49. The SMA actuator of claim 48, wherein the SMAsubstrate comprises Nitinol and the electrically insulative layercomprises a native oxide of Nitinol.
 50. The SMA actuator of claim 35,wherein the electrically insulative layer comprises a nitride.
 51. TheSMA actuator of claim 50, wherein the nitride is selected from the groupconsisting of boron nitride, silicon nitride, and aluminum nitride. 52.The SMA actuator of claim 35, wherein the electrically insulative layercomprises carbide.
 53. The SMA actuator of claim 35, wherein a thicknessof the portion of the electrically insulative layer over which the tracepattern of conductive material is formed is between approximately 0.5micrometer and approximately 1 micrometer.
 54. The SMA actuator of claim35, wherein a thickness of the portion of the electrically insulativelayer over which the trace pattern of conductive material is formed isless than approximately 0.5 micrometer.
 55. The SMA actuator of claim35, wherein a dielectric strength of the portion of the electricallyinsulative layer over which the trace pattern of conductive material isformed is sufficient for an applied operating voltage greater thanapproximately 100V.
 56. The SMA actuator of claim 35, wherein adielectric strength of the portion of the electrically insulative layerover which the trace pattern of conductive material is formed issufficient for an applied operating voltage greater than approximately10V.
 57. The SMA actuator of claim 35, wherein a dielectric strength ofthe portion of the electrically insulative layer over which the tracepattern of conductive material is formed is sufficient for an appliedoperating voltage between approximately 1V and approximately 10V. 58.The method of claim 28, wherein the inorganic material comprises anoxide.
 59. The method of claim 28, wherein the inorganic materialcomprises a nitride.
 60. The method of claim 59, wherein the nitride isselected from the group consisting of boron nitride, silicon nitride andaluminum nitride.
 61. The method of claim 28, wherein the inorganicmaterial comprises a carbide.
 62. A method for manufacturing a shapememory alloy (SMA) actuator, comprising: forming an electricallyinsulative layer including a native oxide on a surface of an SMAsubstrate; and forming a conductive material on a portion of theinsulating layer in a trace pattern; wherein means for forming theelectrically insulative layer is selected from the group consisting ofelectrochemically forming the native oxide, chemically forming thenative oxide and thermally forming the native oxide.